Assessing the Analytical Reliability and Correlation of Hemo Spark+ Against the HemoCue 201 Gold Standard

Abstract

Background: Anemia affects over 50–60% of women of reproductive age, children, and pregnant women in many parts of India (per NFHS and WHO data), contributing to maternal mortality, low birth weight, impaired child development, and reduced productivity. Early detection through hemoglobin (Hb) screening is essential for interventions like iron supplementation, deworming, and nutritional programs. However, traditional lab-based methods (e.g., automated hematology analyzers using cyanmethemoglobin or flow cytometry) are expensive, require trained personnel, infrastructure, and sample transport—often impractical in rural or primary health centers (PHCs), antenatal clinics, schools, or blood donation camps. Accurate and rapid hemoglobin (Hb) estimation is critical for anemia screening and clinical decision-making. This study evaluates the analytical performance of the Hemo Spark+ Hemoglobin meter point-of-care (POC) meter, based on dual wavelength absorption photometry, compared to the HemoCue Hb 201 reference standard. Performance was assessed through statistical interpretation of accuracy, precision, and agreement using both venous and capillary blood samples. Objective: To assess the analytical reliability and correlation of the HemoSpark+ Hemoglobin meter, hemoglobin levels were estimated in parallel with the Hemo Cue Hb 201 hemoglobin meter with both venous and blood samples. To determine if Hemo Spark+ meter is a viable, cost-effective alternative for anemia screening, blood donation, and maternal health programs, especially where portability and ease-of-use are critical. Materials and Methods: This prospective, method-comparison study was conducted to evaluate the diagnostic performance of the Hemo Spark+ against the HemoCue Hb 201 (Reference Method). The study protocol adhered to the CLSI EP09-A3 guidelines for method comparison and bias estimation using patient samples. A total of 321 participants were enrolled, including: Adults (N=236): Stratified by gender (Male/Female). Children (N=85): Defined as individuals under 12 years of age. Two types of blood matrices were collected from each participant to evaluate matrix effects: Capillary Blood: Obtained via a standard finger-prick using a high-flow lancet. Venous Blood: Collected via venipuncture into K2-EDTA vacuum tubes. Venous samples were analyzed within 4 hours of collection to ensure cellular integrity. Results: The Hemo Spark+ hemoglobin meter meets and exceeds the performance requirements for point-of-care anemia screening. With a correlation of 0.9989 and diagnostic sensitivity and specificity exceeding 95%, it provides a reliable, low-bias alternative to the HemoCue Hb 201 for both adult and pediatric populations. The device demonstrated high repeatability and reproducibility across the three critical hemoglobin levels. Intra-Sample (Repeatability): Testing the same sample 20 times on one meter. Low (8.2 g/dL): CV = 1.46; Medium (13.5 g/dL): CV = 0.89; High (17.1g/dL): CV=0.70%; Inter-Sample (Reproducibility): Testing the same sample across 5 different meters. Low (8.2 g/dL): CV = 2.20%; Medium (13.5 g/dL): CV = 1.33%; High (17.1 g/dL): CV = 1.05%; There was no statistically significant difference (p > 0.05) between venous and capillary blood performance. While capillary samples showed a slightly higher standard deviation (+/- 0.12 g/dL) compared to venous samples (+/- 0.08 g/dL), both remained well within the target accuracy and sensitivity/specificity thresholds (> 95%). Conclusion: The Hemo Spark+ hemoglobin meter meets and exceeds the performance requirements for point-of-care anemia screening. With a correlation of 0.9989 and diagnostic sensitivity and specificity exceeding 95%, it provides a reliable, low-bias alternative to the HemoCue Hb 201 for both adult and pediatric populations.